Is NCT06126744 recruiting in New York, NY?

Yes, NCT06126744 is currently recruiting participants at its New York, NY location. This recurrent high grade glioma clinical trial is actively enrolling qualified participants.

How do I join the recurrent high grade glioma clinical trial in New York?

To join this clinical trial in New York, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New York clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Recurrent High Grade Glioma Clinical Trial in New York, NY

About This Recurrent High Grade Glioma Study in New York

This is a Phase 1 open label study designed to assess the safety and tolerability of the oncolytic herpes simplex virus 1 (oHSV1) study drug, MVR-C5252, administered intratumorally by convection-enhanced delivery (CED) in patients with recurrent high-grade glioma. Once the safety and maximum tolerated dose (MTD) is established in the dose escalation portion of the trial, a dose expansion cohort at the recommended phase 2 dose (RP2D) in patients with isocitrate dehydrogenase (IDH) wildtype recurrent glioblastoma (GBM) will evaluate preliminary efficacy of the study drug.

Sponsor: Duke University

Who Can Participate

Inclusion Criteria

Age \>18 years of age

Disease recurrence of at least 1x1cm and a maximum of 3x3cm of enhancing tumor: Dose escalation portion: patients with recurrent high-grade glioma, IDH wt or IDH mutated, grade 3 or grade 4 based on imaging. Dose expansion portion: Recurrent, IDH wt, glioblastoma, WHO grade 4. Diagnosis has be made using the 2021 WHO Classification of Tumors of the CNS.

The neurosurgeon must confirm (a) the tumor location (\> 1 cm from eloquent brain), (b) that the placement of infusion catheter within or through the progressive enhancing tumor is feasible and is at a safe distance to eloquent brain function. These aspects will be determined prior catheter placement on the basis of prior (screening) MRI and then at the time of catheter placement on the basis of a CT scan prior to infusion. The tip of the catheter must be placed as follows:

Within the enhancing portion or in the vicinity of enhancement of target lesion (i.e., infiltrative disease)

≥ 0.5 cm from ventricles

≥ 1 cm deep into the brain

≥ 0.5 cm from the corpus callosum

If a histological or pathological confirmation of recurrence (\< 6 weeks) is not available, a pre-infusion biopsy will be required to confirm recurrence.

Adequate pulmonary function, with a baseline pulse oximetry of at 90% on room air.

The subject must have received standard radiation therapy plus temozolomide and be refractory to radiation therapy plus temozolomide prior to enrollment.

Prior to administration of MVR-C5252, the presence of recurrent tumor must be confirmed by histopathological analysis. (Distinguishing between recurrent active tumor and radiation necrosis is important to avoid delivering MVR-C5252 when there is no active disease). Should participants have further surgical resection at any time following their participation in the study, patients will be invited to make any biospecimens available for correlative research.

Karnofsky Performance Status (KPS) ≥ 70%

platelets ≥ 100,000 unsupported at initial screening, but ≥ 125,000 supported prior to biopsy/catheter insertion

hemoglobin ≥ 9 gm/dL, ANC ≥ 1000/µL

creatinine ≤ 1.5x upper limit of normal (ULN)

total bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 2.5 x ULN (subjects with known or suspected Gilbert's syndrome are excluded if total bilirubin \> 3.0 x ULN or direct bilirubin \> 1.5 x ULN)

PT, aPTT ≤ 1.2 x ULN prior to biopsy (if patient is taking warfarin, INR should be obtained and be \< 2.0)

Able to undergo MRI brain with and without contrast

If the patient is a sexually active female of childbearing potential, whose partner is male, or if the patient is a sexually active male, whose partner is a female of child bearing potential, the patient must use appropriate contraceptive measures for the duration of the treatment and for 6 months afterwards. Female patients of childbearing potential must have a negative serum pregnancy test at the time of screening and within 48 hours of starting the MVR-C5252 infusion.

Signed informed consent approved by the Institutional Review Board

Exclusion Criteria

Prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin

Patients who are pregnant or breastfeeding

Patients with contrast-enhancing tumor crossing the midline, multifocal tumor, infratentorial tumor, tumor in eloquent brain regions, extensive tumor dissemination (subependymal or leptomeningeal), or in unsafe brain regions per the opinion of the treating neurosurgeon

Unstable systemic disease in the opinion of the treating physician.

Active infection requiring systemic therapy or causing fever (temperature \> 38.1˚C) or subjects with unexplained fever (temperature \> 38.1˚C) within 7 days prior to the day of investigational product administration.

Patients on \>4 mg per day of dexamethasone within the 2 weeks prior to admission for MVR-C5252 infusion or systemic therapy with immunosuppressive agents within 28 days prior to admission for MVR-C5252 infusion

Patients who have not completed standard of care treatment prior to participation in this trial

Less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation of recurrent tumor

Treated with immunotherapeutic agents prior to MVR-C5252 treatment, within 4 weeks, alkylating agents within 4 weeks, nitrosoureas within 6 weeks, or non-alkylating chemotherapy within 2 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy

Treated with antiangiogenic agents (i.e., bevacizumab) within 4 weeks before biopsy

Patients who require an attenuated or live vaccine within 28 days prior to the first trial drug administration and during the study treatment period

Prior treatment with any oncolytic virus, cell therapy or gene therapy.

Prior antitumor treatment with intracranial implants, such as Carmustine

Previous history of allergic reactions to similar biological components such as HSV-1, IL-12 or anti-PD-1 antibodies, or with known allergic reactions to any component of the MVR-C5252 prescription, including glycerol.

Systemic use (other than topical) of anti-HSV drugs (including, but not limited to, acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir, etc.)

Patients with cardiac risks including congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry, or a history of myocarditis.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT06126744) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Recurrent High Grade Glioma Treatment Options in New York, NY

If you're searching for recurrent high grade glioma treatment options in New York, NY, this clinical trial (NCT06126744) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced recurrent high grade glioma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all recurrent high grade glioma clinical trials near you to find additional studies recruiting in your area.

Recurrent High Grade Glioma Clinical Trial in New York, NY

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IRB Approved

No-Cost Care

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